Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
- Conditions
- Cancer
- Registration Number
- NCT00110045
- Brief Summary
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.
PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.
- Detailed Description
OBJECTIVES:
Primary
* Determine the activity of caspofungin acetate as first-line therapy for proven or probable invasive aspergillosis, in terms of response rate, in patients with hematologic malignancies or in patients who have undergone hematopoietic stem cell transplantation.
Secondary
* Determine the 84-day response rate in patients treated with this drug.
* Determine the 84-day survival rate in patients treated with this drug.
* Determine the safety of this drug, in terms of the rate of overall drug-related adverse events, the rate of overall drug-related serious adverse events, and the rate of drug-related adverse events leading to treatment discontinuation, in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease and/or type of prior hematopoietic stem cell transplantation (HSCT) (hematologic malignancy or autologous HSCT vs allogeneic HSCT).
Patients receive caspofungin acetate IV over approximately 1 hour once daily on days 1-15 in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) or partial response (PR) after day 15 may continue to receive caspofungin acetate as above until day 84 OR discontinue study treatment after day 15 and shift to an oral antifungal drug for maintenance therapy or prophylaxis, if considered to be in the best interest of the patient. Patients achieving stable disease after day 15 continue to receive caspofungin acetate as above until day 28. These patients then undergo a second evaluation. Patients who maintain stable disease continue to receive caspofungin acetate as above until day 84. Patients achieving CR or PR are treated as per CR or PR treatment described above.
After completion of study treatment, patients are followed weekly for 30 days.
PROJECTED ACCRUAL: A total of 149 patients (87 in stratum 1, 62 in stratum 2) will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate as assessed by standard criteria after completion of study treatment
- Secondary Outcome Measures
Name Time Method Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment Survival rate at 84 days Safety
Trial Locations
- Locations (13)
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Medizinische Poliklinik, Universitaet Wuerzburg
🇩🇪Wuerzburg, Germany
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Ospedale Santa Croce
🇮🇹Cuneo, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa, Italy
Hacettepe University - Faculty of Medicine
🇹🇷Ankara, Turkey
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Ospedale San Martino
🇮🇹Genoa, Italy
Hopital Saint-Louis
🇫🇷Paris, France